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Pharmaceutical Education And Research with Regulatory Links: Innovative drug development strategies and regulatory tools tailored to facilitate earlier access to medicines

Deliverables

Publications

Exploring gastric emptying rate in mini-pigs: Effect of food type and pre-dosing of metoclopramide

Author(s): Laura J. Henze, Brendan T. Griffin, Martin Christiansen, Christoffer Bundgaard, Peter Langguth, Rene Holm
Published in: European Journal of Pharmaceutical Sciences, 2018, ISSN 0928-0987
DOI: 10.1016/j.ejps.2018.03.017

The pig as a preclinical model for predicting oral bioavailability and in vivo performance of pharmaceutical oral dosage forms: a PEARRL review

Author(s): Laura J. Henze, Niklas J. Koehl, Joseph P. O'Shea, Edmund S. Kostewicz, René Holm, Brendan T. Griffin
Published in: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
DOI: 10.1111/jphp.12912

In vitro methods to assess drug precipitation in the fasted small intestine - a PEARRL review

Author(s): Patrick J. O'Dwyer, Chara Litou, Karl J. Box, Jennifer B. Dressman, Edmund S. Kostewicz, Martin Kuentz, Christos Reppas
Published in: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
DOI: 10.1111/jphp.12951

Food for thought: formulating away the food effect - a PEARRL review

Author(s): Joseph P. O'Shea, René Holm, Caitriona M. O'Driscoll, Brendan T. Griffin
Published in: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
DOI: 10.1111/jphp.12957

Biopharmaceutical considerations in paediatrics with a view to the evaluation of orally administered drug products - a PEARRL review

Author(s): Mariana Guimarães, Marina Statelova, René Holm, Christos Reppas, Moira Symilllides, Maria Vertzoni, Nikoletta Fotaki
Published in: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
DOI: 10.1111/jphp.12955

Application of the solubility parameter concept to assist with oral delivery of poorly water-soluble drugs - a PEARRL review

Author(s): Sandra Jankovic, Georgia Tsakiridou, Felix Ditzinger, Niklas J. Koehl, Daniel J. Price, Alexandra-Roxana Ilie, Lida Kalantzi, Kristof Kimpe, René Holm, Anita Nair, Brendan Griffin, Christoph Saal, Martin Kuentz
Published in: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
DOI: 10.1111/jphp.12948

Impact of gastrointestinal disease states on oral drug absorption - implications for formulation design - a PEARRL review

Author(s): Angela Effinger, Caitriona M. O'Driscoll, Mark McAllister, Nikoletta Fotaki
Published in: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
DOI: 10.1111/jphp.12928

Approaches to increase mechanistic understanding and aid in the selection of precipitation inhibitors for supersaturating formulations - a PEARRL review

Author(s): Daniel J. Price, Felix Ditzinger, Niklas J. Koehl, Sandra Jankovic, Georgia Tsakiridou, Anita Nair, René Holm, Martin Kuentz, Jennifer B. Dressman, Christoph Saal
Published in: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
DOI: 10.1111/jphp.12927

Effects of medicines used to treat gastrointestinal diseases on the pharmacokinetics of coadministered drugs: a PEARRL Review

Author(s): Chara Litou, Angela Effinger, Edmund S. Kostewicz, Karl J. Box, Nikoletta Fotaki, Jennifer B. Dressman
Published in: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
DOI: 10.1111/jphp.12983

Lipophilicity and hydrophobicity considerations in bio-enabling oral formulations approaches - a PEARRL review

Author(s): Felix Ditzinger, Daniel J. Price, Alexandra-Roxana Ilie, Niklas J. Köhl, Sandra Jankovic, Georgia Tsakiridou, Simone Aleandri, Lida Kalantzi, René Holm, Anita Nair, Christoph Saal, Brendan Griffin, Martin Kuentz
Published in: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
DOI: 10.1111/jphp.12984

Towards a better understanding of solid dispersions in aqueous environment by a fluorescence quenching approach

Author(s): Simone Aleandri, Sandra Jankovic, Martin Kuentz
Published in: International Journal of Pharmaceutics, Issue 550/1-2, 2018, Page(s) 130-139, ISSN 0378-5173
DOI: 10.1016/j.ijpharm.2018.08.029

Modified Polymer Matrix in Pharmaceutical Hot Melt Extrusion by Molecular Interactions with a Carboxylic Coformer

Author(s): Felix Ditzinger, Uta Scherer, Monica Schönenberger, René Holm, Martin Kuentz
Published in: Molecular Pharmaceutics, Issue 16/1, 2018, Page(s) 141-150, ISSN 1543-8384
DOI: 10.1021/acs.molpharmaceut.8b00920

Application of the relationship between pharmacokinetics and pharmacodynamics in drug development and therapeutic equivalence: a PEARRL review

Author(s): Ioannis Loisios-Konstantinidis, Rafael L. M. Paraiso, Nikoletta Fotaki, Mark McAllister, Rodrigo Cristofoletti, Jennifer Dressman
Published in: Journal of Pharmacy and Pharmacology, Issue 71/4, 2019, Page(s) 699-723, ISSN 0022-3573
DOI: 10.1111/jphp.13070

The PEARRL reviews - innovative drug development strategies tailored to facilitate earlier access to new oral medicines

Author(s): Brendan T. Griffin, Jennifer B. Dressman
Published in: Journal of Pharmacy and Pharmacology, Issue 71/4, 2019, Page(s) 439-440, ISSN 0022-3573
DOI: 10.1111/jphp.13083

New Insights into Using Lipid Based Suspensions for ‘Brick Dust’ Molecules: Case Study of Nilotinib

Author(s): Niklas J. Koehl, René Holm, Martin Kuentz, Brendan T. Griffin
Published in: Pharmaceutical Research, Issue 36/4, 2019, ISSN 0724-8741
DOI: 10.1007/s11095-019-2590-y

Calculation of drug-polymer mixing enthalpy as a new screening method of precipitation inhibitors for supersaturating pharmaceutical formulations

Author(s): Daniel J. Price, Anita Nair, Martin Kuentz, Jennifer Dressman, Christoph Saal
Published in: European Journal of Pharmaceutical Sciences, Issue 132, 2019, Page(s) 142-156, ISSN 0928-0987
DOI: 10.1016/j.ejps.2019.03.006

Toward the establishment of a standardized pre-clinical porcine model to predict food effects – Case studies on fenofibrate and paracetamol

Author(s): Laura J. Henze, Niklas J. Koehl, Joseph P. O'Shea, René Holm, Maria Vertzoni, Brendan T. Griffin
Published in: International Journal of Pharmaceutics: X, Issue 1, 2019, Page(s) 100017, ISSN 2590-1567
DOI: 10.1016/j.ijpx.2019.100017

Combining biorelevant in vitro and in silico tools to simulate and better understand the in vivo performance of a nano-sized formulation of aprepitant in the fasted and fed states

Author(s): Chara Litou, Nikunjkumar Patel, David B. Turner, Edmund Kostewicz, Martin Kuentz, Karl J. Box, Jennifer Dressman
Published in: European Journal of Pharmaceutical Sciences, 2019, Page(s) 105031, ISSN 0928-0987
DOI: 10.1016/j.ejps.2019.105031

Biphasic drug release testing coupled with diffusing wave spectroscopy for mechanistic understanding of solid dispersion performance

Author(s): Sandra Jankovic, Patrick J. O'Dwyer, Karl J. Box, Georgios Imanidis, Christos Reppas, Martin Kuentz
Published in: European Journal of Pharmaceutical Sciences, Issue 137, 2019, Page(s) 105001, ISSN 0928-0987
DOI: 10.1016/j.ejps.2019.105001

Opportunities for Successful Stabilization of Poor Glass-Forming Drugs: A Stability-Based Comparison of Mesoporous Silica Versus Hot Melt Extrusion Technologies

Author(s): Felix Ditzinger, Daniel J. Price, Anita Nair, Johanna Becker-Baldus, Clemens Glaubitz, Jennifer B. Dressman, Christoph Saal, Martin Kuentz
Published in: Pharmaceutics, Issue 11/11, 2019, Page(s) 577, ISSN 1999-4923
DOI: 10.3390/pharmaceutics11110577

Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. Case example: Naproxen

Author(s): Ioannis Loisios-Konstantinidis, Rodrigo Cristofoletti, Nikoletta Fotaki, David B. Turner, Jennifer Dressman
Published in: European Journal of Pharmaceutical Sciences, 2019, Page(s) 105170, ISSN 0928-0987
DOI: 10.1016/j.ejps.2019.105170

Incorporation of HPMCAS during loading of glibenclamide onto mesoporous silica improves dissolution and inhibits precipitation

Author(s): Daniel J. Price, Anita Nair, Johanna Becker-Baldus, Clemens Glaubitz, Martin Kuentz, Jennifer Dressman, Christoph Saal
Published in: European Journal of Pharmaceutical Sciences, Issue 141, 2020, Page(s) 105113, ISSN 0928-0987
DOI: 10.1016/j.ejps.2019.105113

A Novel Rheological Method to Assess Drug-Polymer Interactions Regarding Miscibility and Crystallization of Drug in Amorphous Solid Dispersions for Oral Drug Delivery

Author(s): Georgia Tsakiridou, Christos Reppas, Martin Kuentz, Lida Kalantzi
Published in: Pharmaceutics, Issue 11/12, 2019, Page(s) 625, ISSN 1999-4923
DOI: 10.3390/pharmaceutics11120625

The impact of food intake on the luminal environment and performance of oral drug products with a view to in vitro and in silico simulations: a PEARRL review

Author(s): Christina Pentafragka, Mira Symillides, Mark McAllister, Jennifer Dressman, Maria Vertzoni, Christos Reppas
Published in: Journal of Pharmacy and Pharmacology, Issue 71/4, 2019, Page(s) 557-580, ISSN 0022-3573
DOI: 10.1111/jphp.12999

In‐vitro–in‐silico investigation of the negative food effect of zolpidem when administered as immediate‐release tablets

Author(s): Rafael Leal Monteiro Paraiso, Ayahisa Watanabe, Cord J. Andreas, David Turner, Patricia Zane, Jennifer Dressman
Published in: Journal of Pharmacy and Pharmacology, Issue 71/11, 2019, Page(s) 1663-1676, ISSN 0022-3573
DOI: 10.1111/jphp.13161

The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group

Author(s): Mirko Koziolek, Stefano Alcaro, Patrick Augustijns, Abdul W. Basit, Michael Grimm, Bart Hens, Caroline L. Hoad, Philipp Jedamzik, Christine M. Madla, Marc Maliepaard, Luca Marciani, Annalisa Maruca, Neil Parrott, Petr Pávek, Christopher J.H. Porter, Christos Reppas, Diana van Riet-Nales, Jari Rubbens, Marina Statelova, Natalie L. Trevaskis, Kateřina Valentová, Maria Vertzoni, Dubravka Vitali Č
Published in: European Journal of Pharmaceutical Sciences, Issue 134, 2019, Page(s) 31-59, ISSN 0928-0987
DOI: 10.1016/j.ejps.2019.04.003

On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants: an Exploratory Study Highlighting the Importance of Infant Food

Author(s): Marina Statelova, Konstantinos Goumas, Nikoletta Fotaki, René Holm, Mira Symillides, Christos Reppas, Maria Vertzoni
Published in: The AAPS Journal, Issue 22/1, 2020, ISSN 1550-7416
DOI: 10.1208/s12248-019-0380-4

Polyelectrolytes in Hot Melt Extrusion: A Combined Solvent-Based and Interacting Additive Technique for Solid Dispersions

Author(s): Felix Ditzinger, Catherine Dejoie, Dubravka Sisak Jung, Martin Kuentz
Published in: Pharmaceutics, Issue 11/4, 2019, Page(s) 174, ISSN 1999-4923
DOI: 10.3390/pharmaceutics11040174

Disposition of two highly permeable drugs in the upper gastrointestinal lumen of healthy adults after a standard high-calorie, high-fat meal

Author(s): Christina Pentafragka, Maria Vertzoni, Mira Symillides, Konstantinos Goumas, Christos Reppas
Published in: European Journal of Pharmaceutical Sciences, Issue 149, 2020, Page(s) 105351, ISSN 0928-0987
DOI: 10.1016/j.ejps.2020.105351

On the Usefulness of Two Small-Scale In Vitro Setups in the Evaluation of Luminal Precipitation of Lipophilic Weak Bases in Early Formulation Development

Author(s): Patrick J. O’Dwyer, Georgios Imanidis, Karl J. Box, Christos Reppas
Published in: Pharmaceutics, Issue 12/3, 2020, Page(s) 272, ISSN 1999-4923
DOI: 10.3390/pharmaceutics12030272

Broadband Diffusing Wave Spectroscopy Reveals Microstructuring of Polymer–Drug System


Published in: ISSN 1528-7483
DOI: 10.1021/acs.cgd.0c00267

Combining biorelevant in vitro and in silico tools to investigate the in vivo performance of the amorphous solid dispersion formulation of etravirine in the fed state.

Author(s): Chara Litou, David B. Turner, Nico Holmstock, Jens Ceulemans, Karl J. Box, Edmund Kostewicz, Martin Kuentz, Rene Holm, Jennifer Dressman
Published in: European Journal of Pharmaceutical Sciences, 2020, Page(s) 105297, ISSN 0928-0987
DOI: 10.1016/j.ejps.2020.105297

Measuring pH and Buffer Capacity in Fluids Aspirated from the Fasted Upper Gastrointestinal Tract of Healthy Adults

Author(s): Chara Litou, Dimitrios Psachoulias, Maria Vertzoni, Jennifer Dressman, Christos Reppas
Published in: Pharmaceutical Research, Issue 37/3, 2020, ISSN 0724-8741
DOI: 10.1007/s11095-019-2731-3

Supersaturated lipid-based drug delivery systems – exploring impact of lipid composition type and drug properties on supersaturability and physical stability

Author(s): Alexandra-Roxana Ilie, Brendan T. Griffin, Ruzica Kolakovic, Maria Vertzoni, Martin Kuentz, René Holm
Published in: Drug Development and Industrial Pharmacy, Issue 46/3, 2020, Page(s) 356-364, ISSN 0363-9045
DOI: 10.1080/03639045.2020.1721526

A Novel In Silico Screening Protocol For The Selection Of Optimized Precipitation Inhibitor Systems For Supersaturable Formulations

Author(s): Daniel Price, Christoph Saal, Anita Nair, Jennifer Dressman
Published in: 2017

In Vitro Modelling Of Propranolol Immediate Release And Extended Release Formulations Using A Three Chamber Dissolution Apparatus

Author(s): Patrick O'Dwyer, Karl Box, Robert Taylor, Hayley Watson
Published in: 2017